At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Sr. RA Manager, CMC 

 

YOUR TASKS AND RESPONSIBILITIES

 

Responsible for planning and preparing license maintenance strategy focus on CMC techinicals. For new products, CMC regulatory strategy development should be under direction Independently responsible for CMC regulatory activities for maintenance of marketed products, for new products, which should be under direction Independently responsible for timely tracking and update the projects CMC review status, closely monitor projects progress, foresee the potential CMC queries of HAs for assigned products and seek for the feedback from Has CMC reviewer. Serve as a primary contact person with HAs for CMC techincia review for assigned products/projects, keep CRT to be timely informed about the status. Responsible for internal communication under supervision Participate in a China reulatory team (CRT) and global regulatory team (GRT) per needs, provided local regulatory CMC input into the global development plan for assigned projects after alignment with the supervisor May be assigned other tasks such as SOP/OI Taskforce contribution, RA intelligence and competitor information etc. Ensure the compliance of Company internal Policy/ system/ database/ responsibleprojects and local regulation compliant behavior 

 

 

WHO YOU ARE

 

Advanced technical degree (Ph.D., D.V.M. or Pharm.D.) in life sciences with 4 years of regulatory experience or MS with 6 years of regulatory experience or BS with 8 years of regulatory experience Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) to support filings Basic understanding of chemical drug or biological drug development, manufacture, analytical, quality control, GMP, drug therapy, statistical concepts is desirable. A thorough knowledge of company policies and procedures in drug development and product maintenance requirements Goodcommunication skills, verbal and written, are required Ability to work within a global team framework Strong analytical skills are required Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) tosupport filings Basic understanding of chemical drug or biological drug development, manufacture, analytical, quality control, GMP, drug therapy, statistical concepts is desirable. A thorough knowledge of company policies and procedures in drug development and product maintenance requirements

 

YOUR APPLICATION

If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
 

 

Location:                   

China : BeiJing : BeiJing 

 

Division:

Pharmaceuticals 

 

Reference Code:

835617